Dana-Farber/Harvard Cancer Center (DF/HCC) has a well-developed system for the review, oversight and support of cancer-relevant protocols, regardless of the source of support, which are developed and conducted at DF/HCC member institutions. This system includes: 1) a single Protocol Review and Monitoring System (PRMS);2) a unified data and safety monitoring process (DSMP);3) a common IRB for review of cancer-relevant research;and 4) a centralized infrastructure to support DF/HCC clinical research that is composed of the Protocol Review Office (PRO), Clinical Research Unit (CRU), Biostatistics Core and Protocol-Specific Research Support (PSRS) and other relevant offices. Unified clinical trials informatics for the consortium is managed by the clinical trials informatics team in the CRU. Effective and timely communication and coordination are achieved through strong faculty and administrative leadership, consortium-wide operating policies and procedures and inter-institutional clinical trials committees. Faculty and staff training in the conduct of clinical trials is managed by the CRU's educational team. There is ongoing monitoring of the Center's clinical trials operations by the Executive Committee, external advisors and the External Advisory Board. The PRMS focuses on the scientific merit of protocols, prioritization and feasibility of trial completion. All proposed cancer-relevant research at member institutions must be reviewed and approved by a Scientific Review Committee (SRC) or through expedited administrative scientific review, as permitted by the CCSG for peer-reviewed research, and, on an annual basis, reviewed by the Scientific Progress Review Committee (SPRC). The PRMS received conditional approval at the time of the last CCSG renewal and was awarded full approval in 2006. Concurrently, the Center Director tasked the Associate Director for Administration and the Medical Director of Clinical Trials Operations to lead a comprehensive clinical trials improvement project. This resulted in major enhancements to all aspects of clinical trials operations including quality, conduct, oversight and improvement in review turn around time.
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